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Análisis de marcadores tumorales circulantes en sangre (ALCINA2)

5 de noviembre de 2026 actualizado por: Institut du Cancer de Montpellier - Val d'Aurelle

The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

Descripción general del estudio

Descripción detallada

The new major challenge in the research concerns the circulating biomarkers, which aim at replacing the molecular analyses on tumour tissue obtained by biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.

The study ALCINA 2 rests exactly on the principle of small cohorts, which correspond each to a clinical situation and/or a technique of different implemented detection, so as to generate data of feasibility and proof of concept. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

992

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Montpellier, Francia, 34298
        • Reclutamiento
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
        • Contacto:
        • Contacto:
      • Montpellier, Francia, 34298
        • Reclutamiento
        • ICM
        • Contacto:
          • WILLIAM JACOT

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
  2. Man or woman ≥ 18 years,
  3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion Criteria:

  1. Private persons of freedom or under guardianship,
  2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
  3. Pregnant woman and/or breast-feeding,
  4. Unaffiliated patient to Social Protection System,

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: COHORT 1 BREAST TUMOR/PALBOCICLIB

Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib

BLOOD SAMPLING

blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time

Otros nombres:
  • Muestreo de tumores
Otro: COHORT 2 BREAST TUMOR / RIBOCICLIB

Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib

BLOOD SAMPLING

blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time

Otros nombres:
  • Muestreo de tumores
Otro: COHORT 3 - LUNG CANCER

Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy

Blood samples will be collected at four key time points:

  • baseline (T1),
  • first scan assessment (T2),
  • second scan assessment (T3),
  • and progression (T4).
Otro: COHORT 4 - CCRm

Patient with metastatic colorectal adenocarcinoma

Blood samples will be collected before any treatment

Otro: COHORT 5 - T-DXd

Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd

Blood samples will be collected at four key time points:

  • At the inclusion (T1)
  • Before the beginning of the treatment (cycle 1 day 1) (T2)
  • After the first cycle of T-DXd (cycle 2 day 1) (T3)
  • At progression or at the end of the follow-up (after 3 years) (T4)
Otro: COHORT 6 - Glioma

Patient with grade II, III or IV diffuse glioma

Blood samples will be collected at three key time points:

  • At the inclusion (T1)
  • For patients starting treatment at the time of inclusion (T2):
  • Chemotherapy: 3 months after inclusion,
  • Concurrent chemoradiotherapy with Temozolomide: 4-6 weeks after completion of radiotherapy,
  • For patients starting treatment at the time of inclusion: at the time of tumor progression if occurring within one year of inclusion, or 12 months after inclusion in the absence of progression (T3).
Otro: COHORT 7 - CIRCUS 2

Patients with non-metastatic colon cancer

Blood samples will be collected before any treatment

Otro: COHORT 8 - CTC-AXL Breast

Patients with treatment-naive metastatic breast cancer with distant metastases

Blood samples will be collected at five key time points:

  • At the inclusion
  • At follow-up visit 2 to 6, every 3 months
Otro: COHORT 9 - ImmunoTNBC

Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated.

Blood samples will be collected at four key time points:

  • At the inclusion before the beginning of the treatment (Cycle 1 Day 1)
  • After the first cycle of the first chemo-immunotherapy sequence (Cycle 2 Day 1)
  • After the first cycle of the second chemotherapy sequence (Cycle 2b Day 1)
  • After the end of the whole neo-adjuvant chemo-immunotherapy protocol, before surgery
Otro: COHORT 10 - LPS

Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma

Blood samples will be collected before any treatment

Otro: COHORT 11 - LUNG DRIVER

Patients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C

Blood samples will be collected at five key time points:

  • At the inclusion (T1)
  • At first clinical evaluation (T2): 4th week after start of treatment
  • At first scan evaluation (T3a): 8th week after start of treatment
  • At the Nth scan evaluation (T3b, c, ...)
  • At progression (T4)

Tumor sampling :

  • At the inclusion
  • At tumor progression
Otro: COHORT 12 - LMD

Patient with breast cancer and suspected with leptomeningeal metastases

Blood samples will be collected at several points :

  • Inclusion: at the time of suspected leptomeningeal metastases, prior to any specific treatment,
  • Every 4 weeks until meningeal progression, or for a maximum of 4 months,
  • Then every 3 months beyond 4 months until meningeal progression.
Otro: COHORT 13 - RILA STAB

Patients with breast cancer requiring radiotherapy, whatever the tumor stage

Blood samples will be collected before any treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Periodo de tiempo: 4 YEARS

Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients"

4 YEARS

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Periodo de tiempo: 4 YEARS

Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03

4 YEARS
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
Periodo de tiempo: 4 YEARS

Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03

4 YEARS
COHORT 3 : Correlation between response to immunotherapy (progressive versus non-progressive) and the number of circulating tumour cells (CTC) expressing the PDL1 marker at T1 (baseline)
Periodo de tiempo: 4 years

Number of CTCs expressing PDL1 at T1

4 years
COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer
Periodo de tiempo: 1 year

Expression of the MS9 mRNA biomarker

1 year
COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment
Periodo de tiempo: 4 years

Progression-Free Survival (the primary outcome measure being the HR between CTC+ and CTC- patients, using the HER2+ CTC count at baseline)

4 years
COHORT 6 : To develop a computerised procedure for diagnosing glioma based on a nucleoside profile obtained by mass spectroscopy, using Artificial Intelligence
Periodo de tiempo: 4 years

Positive predictive value and negative predictive value of the signature to discriminate glioma vs. no glioma

4 years
COHORT 7 : to optimise the culture of circulating tumour cells (CTCs)
Periodo de tiempo: 4 years

Median number of CTCs 1 month after inclusion

4 years
COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique
Periodo de tiempo: 4 years

Concordance rate of CTC-AXL measurement (at inclusion) by EPIDROP technique (AXL(-): 0 vs AXL(+): ≥1) and CellSearch technique (AXL(-): 0 vs AXL(+): ≥1)

4 years
COHORT 9 : to evaluate the predictive value of circulating immune populations for response to neo-adjuvant chemo-immunotherapy (according to pCR) in patients with early TNBCs, by performing an immunomonitoring before, during and after the treatment.
Periodo de tiempo: 4 years

Response to treatment is defined as a pathological complete response (i.e. no residual invasive tumor in breast and axillary lymph nodes (ypT0ypN0)) after neo-adjuvant therapy.

4 years
COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles
Periodo de tiempo: 4 years

Sensibility and specificity of circulating MDM2 DNA in circulating vesicles for LPS diagnosis

4 years
COHORT 11 : to demonstrate a correlation between tumour progression under targeted therapy against EGFR (DEL19; L858R), KRAS G12C and the number of CTCs expressing the HES 1 marker at progression (T4)
Periodo de tiempo: 4 years

Number of CTCs expressing HES 1 to T4

4 years
COHORT 12 : to assess the sensitivity of the hepcidin assay in blood for the diagnosis of leptomeningeal metastases of breast cancer, the gold standard being cytological examination of CSF (up to 3 samples).
Periodo de tiempo: 4 years

Sensitivity of the hepcidin value in the 1st blood sample for the diagnosis of leptomeningeal metastases

4 years
COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)
Periodo de tiempo: 1 year

The mean RILA at 24h (D1), 48h (D2), 72h (D3) and 96h (D4) will be compared. Equivalences between conditions ((1) 24h and 48h, (2) 24h and 72h, (3) 24h and 96h) will be assessed using Passing & Bablok regression and/or paired t-test. Also, linear regressions between 24h, 48h, 72h and 96h for the same patients will be evaluated in order to determine, if necessary, a conversion formula.

1 year

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de mayo de 2018

Finalización primaria (Estimado)

29 de mayo de 2029

Finalización del estudio (Estimado)

29 de mayo de 2032

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2019

Primero enviado que cumplió con los criterios de control de calidad

16 de julio de 2019

Publicado por primera vez (Actual)

19 de julio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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